Perform calibration, maintenance, and validation of Stability Chambers and pharmaceutical manufacturing equipment. Develop and manage equipment maintenance schedules in compliance with GMP standards. Troubleshoot and resolve equipment issues, minimizing downtime and ensuring suitability for stability studies and manufacturing. Lead validation activities and manage equipment modifications, adhering to SDLC and Change Control procedures. Collaborate with internal teams and external service providers on equipment upgrades and software implementations. Maintain accurate documentation, including calibration logs, validation reports, and compliance records (e.g., Annual and Periodic Reviews). Support continuous improvement initiatives within the Equipment Support Unit (ESU). Ensure compliance with cGMP, safety protocols, and site guidelines. Qualifications & Skills:
Degree in a relevant field (e.g., Engineering or Science). Experience in calibration, maintenance, and validation of laboratory and manufacturing equipment, especially Stability Chambers. Strong knowledge of GMP regulations and pharmaceutical stability testing. Familiarity with SAP and other ERP systems is advantageous. Excellent problem-solving, organizational, and communication skills. Ability to work effectively with cross-functional teams and external contractors in a regulated environment. Newcastle upon Tyne // Contract Up to £65,000
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